Notice2024-19039
AI in Biopharmaceuticals Industry Roundtable
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 26, 2024
Issuing agencies
Commerce DepartmentInternational Trade Administration
Abstract
Through this notice, the International Trade Administration (ITA) of the Department of Commerce announces a roundtable discussion with industry representatives and U.S. government officials on strategies to increase U.S. industry competitiveness and support adoption of artificial intelligence (AI) in the U.S. biopharmaceutical industry and the adoption of AI in drug discovery and development, biopharmaceutical manufacturing, clinical trial design, and supply chain management. ITA invites applications from industry representatives to participate in the roundtables. Applicants should be existing producers or prospective new market entrants with medicines that are or will be produced or developed in the United States and exported overseas.
Full Text
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<title>Federal Register, Volume 89 Issue 165 (Monday, August 26, 2024)</title>
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[Federal Register Volume 89, Number 165 (Monday, August 26, 2024)]
[Notices]
[Pages 68394-68395]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19039]
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DEPARTMENT OF COMMERCE
International Trade Administration
AI in Biopharmaceuticals Industry Roundtable
AGENCY: International Trade Administration, Department of Commerce.
ACTION: Notice.
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SUMMARY: Through this notice, the International Trade Administration
(ITA) of the Department of Commerce announces a roundtable discussion
with industry representatives and U.S. government officials on
strategies to increase U.S. industry competitiveness and support
adoption of artificial intelligence (AI) in the U.S. biopharmaceutical
industry and the adoption of AI in drug discovery and development,
biopharmaceutical manufacturing, clinical trial design, and supply
chain management. ITA invites applications from industry
representatives to participate in the roundtables. Applicants should be
existing producers or prospective new market entrants with medicines
that are or will be produced or developed in the United States and
exported overseas.
DATES:
Events: The roundtable will be held on Wednesday, October 16, 2024,
from 2:30 p.m. to 4:30 p.m., Eastern Daylight Time.
Event Registration: ITA will evaluate registrations based on the
submitted information (see below) and inform applicants of selection
decisions, which will be made on a rolling basis until a maximum of 20
participants have been selected.
ADDRESSES: Event: The roundtable will be held via Microsoft Teams, and
the link for the meeting will be provided to selected and registered
participants.
FOR FURTHER INFORMATION CONTACT: Liam Kraft at 771-216-4432 or via
email at <a href="/cdn-cgi/l/email-protection#c68ea3a7aab2ae878f86b2b4a7a2a3e8a1a9b0"><span class="__cf_email__" data-cfemail="0d45686c6179654c444d797f6c6968236a627b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: AI is anticipated to yield significant
growth opportunities for the healthcare sector. With AI regulation and
policy formation still nascent in many markets, it is important to
understand the implications of changes in these areas for U.S.
healthcare industry stakeholders as adoption of AI grows across the
biopharmaceutical industry. This discussion will help position ITA to
work with U.S. industry stakeholders in ways that can enhance U.S.
industry competitiveness in overseas markets and reduce current or
future trade barriers faced by companies in this space.
The Department seeks individual input and views at the 10/16/2024
roundtable regarding overseas competitiveness of U.S. companies using,
or planning to incorporate, AI in how they produce and commercialize
biopharmaceuticals. Participants will be encouraged to provide any
relevant feedback on this issue during the roundtable, which may
include comments on the following non-exhaustive list of possible
topics:
<bullet> With the introduction of technologies such as foundational
models and general-purpose AI, what regulatory and policy shifts is
your company monitoring in global markets that might affect adoption of
AI in the production and commercialization of biopharmaceuticals? How
do you anticipate these changes may affect your company's global
competitiveness?
[[Page 68395]]
<bullet> Which markets, given shifting regulatory and policy
landscapes, present the most promising commercial environments for
adopting AI in the biopharmaceutical industry, from your experience?
<bullet> How do you assess the potential for public-private
partnerships (P3s) to support efforts in the healthcare sector to adopt
AI in the development and commercialization of biopharmaceuticals in
global markets? What would a successful P3 in this space look like?
<bullet> What kinds of strategic international engagements do you
believe would be most effective in creating a more conducive
environment for the U.S. biopharmaceutical industry to adopt AI and
strengthen its competitiveness in overseas markets?
<bullet> What kinds of trade barriers are you seeing or
anticipating that might negatively affect U.S. competitiveness? Where
do you encounter these barriers? How do you think the barriers can be
reduced, removed, or prevented?
[cir] What are the implications of regulations and policies around
health data in foreign markets for adoption of AI in the U.S.
biopharmaceutical industry?
[cir] What are the implications of how foreign governments are
addressing intellectual property considerations in relation to AI-
assisted drug development?
The event is closed to press and the public. Industry participation
is limited to a maximum of 20 qualifying industry representatives.
Selection
To attend, participants should submit the below information to
<a href="/cdn-cgi/l/email-protection#aee6cbcfc2dac6efe7eedadccfcacb80c9c1d8"><span class="__cf_email__" data-cfemail="eda5888c819985aca4ad999f8c8988c38a829b">[email protected]</span></a> by no later than 10/9/2024. ITA will evaluate
registrations based on the submitted information (and based on the
criteria below) on a rolling basis until a maximum of 20 participants
have been selected for each roundtable and inform applicants of
selection decisions.
Applicants are encouraged to send representatives at a sufficiently
senior level to be knowledgeable about their company's capabilities,
interests, and challenges in the global AI in healthcare market. Due to
time constraints, there is a limit of one person to speak on behalf of
each company.
Applicants should include the following information in their
response email:
<bullet> Name of attendee and short bio.
<bullet> Name of company and brief company description.
<bullet> A statement self-certifying how the company meets each of
the following criteria:
1. It is not majority owned by a foreign government entity (or
entities).
2. It is an existing provider or prospective new market entrant, of
biopharmaceuticals that are or will be produced in the United States
and that feature use of AI/ML in one or more of the following business
areas: drug discovery/development (e.g., target identification, disease
modeling, de novo drug design, pre-clinical development), clinical
trials (e.g. patient recruitment, trial design), drug manufacturing
(e.g., process optimization, drug synthesis and formulation), and
supply chain management (e.g., predictive modeling, demand
forecasting).
3. The representative will be able to attend the entire roundtable.
Selection will be based on the following criteria:
<bullet> The company's production or production plans with respect
to AI in drug discovery/development, clinical trials, drug
manufacturing, and supply chain management.
<bullet> The company's experience in leveraging AI to produce
biopharmaceuticals that are exported from the United States to overseas
markets.
<bullet> Suitability of the representative's position and biography
to be able to engage in the conversation.
<bullet> Ability of the company to contribute to the roundtable's
purpose of seeking individual input and views on policies and
initiatives that strengthen U.S. industry competitiveness of U.S.
exports.
Dated: August 20, 2024.
Amanda Lawrence,
Acting Director, Office of Health Industries, International Trade
Administration.
[FR Doc. 2024-19039 Filed 8-23-24; 8:45 am]
BILLING CODE 3510-DR-P
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